Biomedical Research COVID-19 Impact Assessment: Lessons Learned and Compelling Needs

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National Academy of Medicine ̶ NAM Perspectives Discussion Paper
Biomedical Research COVID-19 Impact Assessment: Lessons Learned and Compelling Needs
By Nakela L. Cook and Michael S. Lauer
July 26, 2021 | Discussion Paper :: 28 pages
NAM Perspectives. Discussion Paper, National Academy of Medicine, Washington, DC.
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The COVID-19 pandemic, a public health emergency of unprecedented scale and consequences, has revealed vulnerabilities in our health care system and public health infrastructure, yet also serves as a remarkable learning opportunity for transformational changes. Effects of the COVID-19 pandemic touch every aspect of life in ways not previously imagined—the biomedical and health research enterprises are no exception. Preexisting stresses in the research sector’s workforce, processes, and organizations have been exacerbated in the sector’s quest to effectively generate meaningful information in response to the pandemic and deliver research in new and innovative ways.

The COVID-19 pandemic revealed the necessity to enhance the ability for researchers to share data through interoperable and customizable systems to enable rigor, reproducibility, and efficiency. This properly stewarded data essential for research is available and actionable, but trust remains a critical issue in establishing and maintaining data sharing entities [147].

Despite the rapid innovation occurring during the COVID-19 pandemic, longstanding problems remain. The disproportionate burden of COVID-19 cases and outcomes amongst lower-income populations and communities of color underscores the need to address the lack of diversity of clinical research participants as a top priority. The type of causal, clinical, and population-related intervention studies that may have a critical impact on outcomes in this pandemic necessitated the inclusion of a large, diverse pool of participants most adversely affected and traditionally underrepresented in research.

Government funding focused on community engagement in research can certainly be a lever to promote diversity in study participation, as regulatory bodies seek to ensure the safety and efficacy of therapies across diverse populations [151]. This paper describes the current status of research and the challenges, lessons learned, and the potential, if the challenges are overcome, for a longer-term impact beyond the pandemic to enhance the resilience and diversity of the biomedical research workforce. These lessons learned can also be applied to help advance the rapid translation of research into practice (from basic science to clinical and population settings to applied public health), promote the sharing of data for delivering near real-time results in a clinical setting, and elevate community and participants as equal partners in research…

Summary and Priorities 
Assessing the Impact
The COVID-19 pandemic will have long-standing implications for the research enterprise, which may not return to pre-pandemic operations. A critical priority over the next 6–12 months will be to assess, in both quantitative and qualitative terms, the ongoing and longer-term impact of the pandemic, including opportunities for research to continue to help mitigate and  overcome the pandemic, ensuring the future of the research enterprise is protected, and learning and transforming research to capitalize on lessons from the pandemic response. The Council on Governmental Relations posted a working paper in August 2020 describing a Research Impact Metric by which institutions can assess their operations. The working paper describes a new “Pandemic Normal” characterized by ongoing slow-downs, changes in operations (e.g., shift work, required protective equipment), supply challenges, core facility disruptions, slowed hiring and promotion, and perhaps above all, a great deal of uncertainty [36]. A recently published landscape review described some of the uncertainties: the trajectory of federal funds and policies, the role of charitable foundations, the impact of declines in non-research revenues on research operations, whether future shut-downs may be needed as the pandemic worsens, what the long-term effects on research collaborations (positive and negative) will be, how changes in rapid scientific communication and peer review will evolve, whether research will return to “normal” levels of productivity and on what timeline, and what will happen to the scientific workforce [140]…

Research Participants and Public Participation in Research
This pandemic has created an imperative for communication, collaboration, and coordination across sectors that could not be stronger. Actions and considerations include the following:
:: The establishment of meaningful partnerships and trust with affected communities as research partners is central to the path forward to combat high levels of distrust of scientists and researchers. Partnerships begin with the identification and involvement of community brokers and subsequently identified community entities in understanding the purpose of research studies, setting research priorities, and translating information to communities.

:: Engagement of stakeholders, patients, and communities leveraging community brokers toward building trust and trustworthiness and enhancing diverse participation in research.

:: Broad scientific communications enhance the value of research conveyed to the public and build trust among individuals, organizations, and broader communities.

In the face of unprecedented challenges and urgent necessity, the biomedical and health research enterprise has the potential to deliver the discovery, translation, and implementation science related to vaccines and therapeutics required to end the COVID-19 pandemic. To propel the entire sector toward a holistic approach, it is crucial that all components of the research ecosystem collaborate on a multifaceted transformation that enhances the resilience and diversity of the research workforce and innovates in funding processes and partnerships to maintain the viability of research efforts during a crisis. The research sector of the future accelerates the translation of knowledge to care and public health action, delivers on long-standing data sharing efforts, and coordinates across health and health care. Essential to the sector’s efforts to innovate and achieve is the elevation of communities and participants as equal partners in research while engaging the public in science.